ClinicalTrials.gov record NCT04814394

The Significance of Release of T-follicular Helper and T-follicular Regulatory Cells in Autoimmune Haemolytic Anemia Before and After Tratment

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Aug 22, 2026

The Significance of T-follicular Helper and T-follicular Regulatory Cells in Autoimmune Haemolytic Anemia

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.The registry record was last updated on Oct 26, 2021, about 4 years ago, so the status shown may be out of date. The study team or the registry can confirm.

Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.

Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.

SexAll

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is a retrospective, observational case-control study that measures blood levels of T-follicular helper (Tfh) and T-follicular regulatory (Tfr) cells in people with autoimmune hemolytic anemia (AIHA) and in controls. The study uses flow cytometry on peripheral blood samples taken at diagnosis and after treatment. It is described as including patients with AIHA who are not on treatment.

What it is studying. The study tests the proportions of circulating T-follicular helper (Tfh) and T-follicular regulatory (Tfr) cells, and the Tfh:Tfr ratio, in people with autoimmune hemolytic anemia at diagnosis and after treatment.

What the researchers hope to learn. To document the proportion of circulating T-follicular helper and T-follicular regulatory cells in AIHA and to measure the ratio between these cell types at diagnosis and after treatment, contributing to understanding immune cell involvement in AIHA.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

we study the circulating T-follicular regulatory and T-follicular regulatory cells in autoimmune hemolytic anemia.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Diagnostic test: flowcytometry

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

Patients diagnosed as autoimmune hemolytic anemia, primary or secondary, male or female, any age but not on treatment

Exclusion criteria

Pregnancy or breast-feeding women
Patients treated with corticoids or immunosuppressant.
Patients with hematological malignance.
Patients with alloimmune hemolytic anemia as ABO incompatibility or transplant patients

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

Autoimmune hemolytic anemia (AIHA) is an acquired autoimmune disease resulting in the production of antibodies directed against the patient's red blood cells (RBCs) causing shortened erythrocyte lifespan. The main pathogensis of the disease is autoantibodies (Ab) that directed against erythrocytes, with or without complement (C) activation. The most common form of AIHA is warm AIHA characterized by the presence of warm-type autoantibodies-immunoglobulin G (IgG) which reacts optimally at 37 °C, causing RBC extravascular destruction by tissue macrophages . Previous studies of the etiology and pathogenesis of AIHA have focused on the autoreactive B cells that have escaped tolerance mechanisms and regulatory T cells (Treg). The main treatment of AIHA includes RBC transfusion and immune system inhibitors such as corticosteroids. During an immune response, CD4 Th cells can differentiate into several unique effector lineages that promote different immune responses via the secretion of distinct types of cytokines. T follicular helper (Tfh) cells are a CD4 T cell lineage whose major function is to help B cells form germinal centers (GCs) and produce high-affinity antibodies(6). Tfh cells are characterized by expression of the CXCR5, the transcriptional repressor B cell lymphoma 6 (Bcl-6), programmed death 1 (PD-1), and inducible costimulator (ICOS). Follicular regulatory T (Tfr) cells are a newly identified subset of Treg cells that coexpress markers of both Treg cells and Tfh cells. In addition to expressing Tfh-related markers, Tfr cells also express regulatory markers, such as FoxP3, CD25, CTLA-4, IL-10, and transforming growth factor β (TGFβ). TFR cells represent a highly specialized subpopulation of Foxp3+ Tregs that co-express TFHfeatures, such as Bcl-6, CXCR5, ICOS, PD-1 and Treg features CD25 and Foxp3. TFR cells have the ability to inhibit TFH activation and cytokines production and suppress B cell GL7 and B7-1 expression and limited class switch recombination occurring in the GC via high expression of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) and production of inhibitory cytokine- interleukin 10 (IL-10) and transforming growth factorβ (TGFβ)(5). The involvement of TFR cells in the pathogenesis of human autoimmune diseases remains speculative, but an alteration of the TFR:TFH ratio is observed in the blood of patients suffering from several autoimmune diseases, such as child immune thrombocytopenia, and rheumatoid arthritis.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will provide a peripheral blood sample for flow cytometry; the study will examine markers (CD4, CD25, FOXP3, PD-1) to measure T-follicular helper and T-follicular regulatory cells. The primary outcomes list measurements at diagnosis and after treatment, but the registry does not give exact visit timing or number of samples. Healthy volunteers in the control group would also provide a blood sample. The record does not describe other procedures, visit schedules, or participant support services.

How the study is structured. A retrospective case-control observational study. Researchers analyze blood samples using flow cytometry to compare Tfh and Tfr cell levels between people with AIHA and control individuals.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
The registry says recruitment has not started. When is it expected to open, and can I register interest now?
No sites are listed on the registry yet. Where will the study take place?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on autoimmune hemolytic anemia

Clinical trials49 trials listed for autoimmune hemolytic anemiaEvery trial the registry lists for autoimmune hemolytic anemia, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in autoimmune hemolytic anemia researchLatest monthly update: September 2026. Includes: Negative DAT cases. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Apr 1, 2022 (estimated)
Primary completion: Dec 1, 2023 (estimated)
Study completion: Dec 1, 2026 (estimated)
Target enrollment: 50 participants (estimated)
Last updated on registry: Oct 26, 2021
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Assiut University
Principal investigator: Mohamed gamal, Doctor
Assiut University

Participating sites

Study locations have not been posted on ClinicalTrials.gov yet. This study is not yet recruiting, so sites may be added when recruitment begins.

Terms used on this page · explanations by MedicalUpdates.ai

immunosuppressant: A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
corticosteroids: Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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